The following data is part of a premarket notification filed by Nms Pharmaceuticals, Inc. with the FDA for Tru-level Control Immunoassay Controls.
| Device ID | K861202 |
| 510k Number | K861202 |
| Device Name: | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry Rucker |
| Correspondent | Perry Rucker NMS PHARMACEUTICALS, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1987-01-09 |